NCT04785430

Brief Summary

It is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. However, the risks of incarceration in hernias have not been fully revealed.To better understand the factors associated with incarceration in inguinal hernia, the investigators will examine patients who will apply to our clinic for inguinal hernia and undergo elective and emergency inguinal hernia surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

March 1, 2021

Last Update Submit

March 4, 2021

Conditions

Incarcerated Inguinal HerniaStrangulated Inguinal HerniaInguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Hernia defect size

    Measurement of fascial defect causing the hernia, using USG or CT

    2 hours after physical examination

Secondary Outcomes (3)

  • Constipation

    1 years

  • Age

    up to 24 weeks

  • Body Mass Index

    up to 24 weeks

Study Arms (2)

Patients who underwent elective inguinal hernia surgery

Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia and underwent hernia repair surgery.

Patients who underwent emergency inguinal hernia surgery

Patients who have applied to the emergency clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.

You may qualify if:

  • Ages between 18-80
  • Primary and recurrent inguinal hernias
  • Incarcerated / strangulated inguinal hernias

You may not qualify if:

  • Younger than 18, older than 80
  • Pregnancy
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırkoy Dr.Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Sneiders D, Yurtkap Y, Kroese LF, Kleinrensink GJ, Lange JF, Gillion JF; Hernia-Club Members. Risk Factors for Incarceration in Patients with Primary Abdominal Wall and Incisional Hernias: A Prospective Study in 4472 Patients. World J Surg. 2019 Aug;43(8):1906-1913. doi: 10.1007/s00268-019-04989-x.

    PMID: 30980102BACKGROUND

  • Kunduz E, Sormaz IC, Yapalak Y, Bektasoglu HK, Gok AF. Comparison of surgical techniques and results for emergency or elective femoral hernia repair. Ulus Travma Acil Cerrahi Derg. 2019 Nov;25(6):611-615. doi: 10.14744/tjtes.2019.04524.

    PMID: 31701494BACKGROUND

  • Kandemir H, Donmez T, Surek A, Gumusoglu AY, Karabulut M, Canoz O, Kaya A. Risk factors for incarceration in groin hernia: a prospective observational study. Hernia. 2025 Apr 12;29(1):142. doi: 10.1007/s10029-025-03331-w.

    PMID: 40216639DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Turgut Donmez

    Bakırkoy Dr. Sadi Konuk Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bakirkoy EAH

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 5, 2021

Study Start

January 1, 2021

Primary Completion

August 1, 2022

Study Completion

January 1, 2023

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

TU(1)